The FOSAMAX Induced Femur Fractures - HB Litigation Conferences

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AdComm Hearing Location Marriott Inn and Conference Center University of Maryland University College (UMUC) 3501 University Blvd. East Adelphi, Maryland
FDA BP AdComm Speaker and Written Submission Contact Information Kalyani Bhatt Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Avenue WO31-2417 Silver Spring, Maryland 20993-0002 Phone: 301-796-9001 Fax: 301-847-8533 E-mail: ACRHD@fda.hhs.gov
Page 1 and 2: The FOSAMAX Induced Femur Fractures
Page 3 and 4: Fosamax indications include: • Tr
Page 5 and 6: Normal Moderate Osteoporosis Severe
Page 7 and 8: Pathophysiology of the Injury The l
Page 9 and 10: FOSAMAX Atypical Femur Fractures (A
Page 11 and 12: Fracture Intervention Trial (FIT)
Page 13 and 14: Dr. Susan Ott M.D. “I believe the
Page 15 and 16: T-1.8; 5 yrs on alendronate; FIT N
Page 17 and 18: Flex Fracture Outcome Years 5-10 %
Page 19 and 20: Unusual Mid-shaft Fractures during
Page 21 and 22: Structural effects of long-term bis
Page 23 and 24: Femoral insufficiency fractures ass
Page 25 and 26: Management recommendations: Post-op
Page 27 and 28: JAMA, Park-Wyllie 2011: BP Use and
Page 29 and 30: Fosamax Label: Timeline
Page 31 and 32: Fosamax 2010 Task Force Report
Page 33 and 34: Information for FDA warning to doct
Page 35 and 36: Fosamax Label Warnings/Precautions:
Page 37 and 38: Fosamax Label Warnings/Precautions:
Page 39 and 40: Jan. 2011: Update on Femur Fracture
Page 41: FDA Bisphosphonate Advisory Committ

The FOSAMAX Induced Femur Fractures - HB Litigation Conferences

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